Manager of Regulatory Operations

Conteúdo do emprego

Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion.

Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of multiple, first-ever disease treatments at speeds faster than the industry average.

As a result of their partnership with Regeneron Pharmaceuticals to clinically develop, commercialise and distribute Evkeeza® (Evinacumab) across Europe, we are seeking a Manager of Regulatory Operations who will play a pivotal role in driving this launch. This role is on a permanent basis located in Basel, with flexibility to work from home.

Responsibilities

• Accountable for quality control of submissions, its contents and backbone, both manually and through appropriate validation software applications.
• Organise and electronically compile all components of Regulatory Agency submissions including, but not limited to: eCTDs - National and Centralized Procedures; Post Marketing/Life-cycle Management: Type Ia, Ib and II Variations & Renewals; Orphan Drug Documents, Scientific Advice and PIPs.
• Prepare submission-ready electronic documents utilizing industry-standard authoring, document management and publishing tools to ensure electronic submissions meet all required standards and technical requirements within specified timelines. This would be both with regard to Word format (use of relevant templates, formatting, insertion of Word hyperlinks, etc.) and PDFs (using Adobe Acrobat and ISIToolbox).
• Report submissions through the relevant gateways/portals (e.g. EMA Submissions Gateway, Central European Submission Portal (CESP), IRIS) and/or other channels.
• Guarantee final document components are electronically archived according to the departmental practices.
• Participate in overall planning activities for submission timelines in accordance with project plans. Maintains submission tracking information and informs project teams and management on real time status of business-critical submissions.
• Assist with software validation, testing of new releases and new applications, and system implementation, as required.
• Offer Veeva Vault user support for members of the company who contribute documents for submissions to competent authorities.
• Deliver input to quality documents related to the work of Regulatory Operations, i.e. SOPs, work instructions and checklists related to global templates, electronic document management, electronic submission processes, and archiving.
• Partake in supporting and promoting current initiatives in moving the company forward with electronic submissions and electronic archives.
• May borderline with cross-functional teams and/or content authors to discuss routine submission preparation and content.
• May occasionally assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures.
• Enthusiastically collaborates with US-based Regulatory Operations colleagues to load balance submission activities.
  

Skills & Requirements

• A BA or a BS degree with at least six years of demonstrated experience in a Regulatory Operations role within the pharmaceutical or biotech industry, or an equivalent combination of education and experience.
• Current and very strong working knowledge of electronic document and submission standards and requirements (CTD/eCTD structure) applicable to the EU, US and global regulatory environments.
• Key understanding of regulatory guidance in the EU.
• Knowledge of working effectively in a cross-cultural and matrix environment.
• Customer-oriented attitude.
• High attention to detail: accurate and meticulous with an ability to detect and correct errors/inconsistencies in documents.
• Exceptional Microsoft Word and Adobe Acrobat skills.
• Established ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organisational and problem-solving skills, follow-up skills)
• Ability to manage multiple ongoing projects simultaneously.
• Ability to communicate effectively in English (spoken and written).
• Self-motivated, with initiative and ability to work in a fast-paced, high-volume environment.
• This position requires the ability to master new technical skills and apply them to projects as the industry and the company evolve.
• Must demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines in order to meet required timelines.
  

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Josh Thompson on +44 203 987 6282.

A Full Job Description Is Available On Request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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